NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM

• K Number: K042384
• Device Name: NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
• Manufacturer: CYBERKINETICS, INC. (CKI)
• Date Cleared: 2005-03-29 ( 209 days)
• Product Code: GZL
• Regulation Number: 882.1330

Intended Use

The NeuroPort™ Array System (Neuroport Electrode) is intended for temporary (<30 days) recording and monitoring of brain electrical activity.

Device Description

The NeuroPort™ Array System (Neuroport Electrode) is comprised of a base approximately 4 mm x 4 mm dimensionally with 100 microelectrodes. Each microelectrode is approximately 1 mm long. The lead connects the microelectrode array to the percutaneous pedestal connector.

Predicate Devices

Ad-Tech Spencer® Depth Electrode

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device for recording brain electrical activity using microelectrodes and does not mention any AI or ML components for analysis or processing of the recorded data.

Therapeutic

No
The device is described as "intended for temporary (

Diagnostic

Yes
The device is intended for "recording and monitoring of brain electrical activity," which is a diagnostic function used to assess a patient's condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a base with microelectrodes and a lead connecting to a percutaneous pedestal connector, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
• NeuroPort™ Array System Function: The NeuroPort™ Array System is described as a device for recording and monitoring brain electrical activity. This involves direct interaction with the brain inside the body. It is a device used for physiological measurement, not for analyzing samples taken from the body.

The information provided clearly indicates the device is used for in-vivo (within the living body) measurement of electrical signals, which is not the function of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NeuroPort™ Array System (Neuroport Electrode) is intended for temporary (

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).

Summary

0

K042384

MAR 2 9 2005

510(K) SUMMARY NeuroPort™ Cortical Microelectrode Array System (Neuroport Electrode)

Submitter Name:	Cyberkinetics, Inc.
Submitter Address:	100 Foxborough Boulevard, Suite 240
Foxboro, MA 02035
Contact Person:	Nandini Murthy, V.P. Regulatory Affairs and Quality Systems
Phone Number:	[phone], Extn 103
Fax Number:	[phone]
Date Prepared:	Aug 30, 2004
Device Trade Name:	NeuroPort™ Cortical Microelectrode Array System (Neuroport
Electrode)
Device Common Name:	Depth electrode
Predicate Devices:	Ad-Tech Spencer® Depth Electrode
Device Description:	The NeuroPort™ Array System (Neuroport Electrode) is
comprised of a base approximately 4 mm x 4 mm dimensionally
with 100 microelectrodes. Each microelectrode is approximately
1 mm long. The lead connects the microelectrode array to the
percutaneous pedestal connector.
Intended Use:	The NeuroPort™ Array System (Neuroport Electrode) is
intended for temporary (